A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Subjects With Acute Myeloid Leukemia in Complete Remission

Bristol-Myers Squibb57 个研究点分布在 2 个国家目标入组 19 人2022年1月17日

适应症Acute Myeloid Leukemia

干预措施Oral Azacitidine Placebo

概览

阶段: 2 期
干预措施: Oral Azacitidine
疾病 / 适应症: Acute Myeloid Leukemia
发起方: Bristol-Myers Squibb
入组人数: 19
试验地点: 57
主要终点: Recurrence Free Survival (RFS)
状态: 进行中（未招募）
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.

注册库

clinicaltrials.gov

开始日期

2022年1月17日

结束日期

2026年4月30日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Bristol-Myers Squibb

责任方

Sponsor

入排标准

入选标准

•≥ 55 years of age inclusive at the time of signing the informed consent
•Newly diagnosed, histologically confirmed de novo Acute Myeloid Leukemia (AML) or AML secondary to prior myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
•Should have undergone induction therapy with intensive chemotherapy with or without consolidation therapy as recommended in appropriate guideline(s) or equivalent regimen according to institutional standard: having achieved first complete remission (CR)/complete remission with incomplete blood count recovery (CRi) status within 4 months prior to starting study therapy

排除标准

•Suspected or proven acute promyelocytic leukemia; or AML with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding MDS and CMML
•Prior bone marrow or stem cell transplantation
•Received therapy with hypomethylating agents for MDS and went on to develop AML within four months of discontinuing the therapy with hypomethylating agents
•Have achieved CR/CRi following therapy with hypomethylating agents
•Other protocol-defined inclusion/exclusion criteria apply

研究组 & 干预措施

Oral Azacitidine

干预措施: Oral Azacitidine

Placebo

干预措施: Placebo

结局指标

主要结局

Recurrence Free Survival (RFS)

时间窗: Approximately 17.7 months

The time from randomization to the date of documented relapse after CR or CRi per central review, or death from any cause, whichever occurs first. Participants who are still alive without documented relapse after CR or CRi, or who were lost to follow-up without documented relapse, will be censored at the date of their last response assessment.

次要结局

Overall Survival (OS)(Approximately 17.7 months)
Time to Relapse From CR or CRi(Approximately 17.7 months)
Time to Discontinuation(Approximately 17.7 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Approximately 17.7 months)
Number of Participants With Clinically Significant Changes in Physical Examination(Approximately 17.7 months)
Number of Participants With Clinically Significant Changes in Vital Signs(Approximately 17.7 months)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Examinations(Approximately 17.7 months)
Number of Participants Who Received Concomitant Medication(Approximately 17.7 months)
Mean Change From Baseline in Facit-Fatigue Scale(From C1D1 to C12D1 (approximately 336 days))
Mean Change From Baseline in EQ-5D-5L(From C1D1 to C12D1 (approximately 336 days))
Pharmacokinetic Evaluation: CMax(on C1D1 (after first dose on day 1))
Pharmacokinetic Evaluation: Tmax(on C1D1 (after first dose on day 1))
Pharmacokinetic Evaluation: AUC(0-T)(on C1D1 (after first dose on day 1))
Pharmacokinetic Evaluation: AUC(INF)(on C1D1 (after first dose on day 1))
Pharmacokinetic Evaluation: T-Half(on C1D1 (after first dose on day 1))
Pharmacokinetic Evaluation: CLT/F(INF)(on C1D1 (after first dose on day 1))
Pharmacokinetic Evaluation: Vz/F(on C1D1 (after first dose on day 1))